Non Alcoholic Fatty Liver DiseasePhase 2NCT07104786
Comparison of Effectiveness of Obeticholic Acid With Vitamin E in Patients of Non-alcoholic Fatty Liver Disease
A Phase 2 study testing Obeticholic Acid 10 MG and Vitamin E 400mg in people with Non Alcoholic Fatty Liver Disease, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
This study was conducted on patients presenting to Mayo Hospital, Lahore from 24th August, 2023 till 23rd May, 2024. Ninety patients conforming to the inclusion criteria were selected via simple random sampling technique and divided into two groups. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Alcoholic Fatty Liver Disease
- What is being tested?
- Obeticholic Acid 10 MG and Vitamin E 400mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Aug 2023to 23 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting adults of either gender between 18-75 years of age
- Any grade of NAFLD on ultrasonography (Grade 1 to 3)
- Raised ALT >1.5 times the upper normal limit. (Normal reference <40 IU in males, <32 IU females)
Who cannot join
- Patients with significant alcohol intake (more than 20 g/day in women and >30g/day in men)
- History of taking drugs that may cause fatty liver (i.e. tamoxifen, valproic acid, amiodarone, methotrexate, steroid, oral contraceptive pills)
- Patients with co-morbid conditions like Diabetes, Chronic Obstructive Pulmonary Disease, Chronic Kidney Disease, Congestive Cardiac Failure, Hypothyroidism
- Pregnant and lactating females
- Patients with history of recent myocardial infarction, cirrhosis (decompensated liver) and portal hypertension
- Patients taking drugs known to have significant interaction with Obeticholic acid or vitamin E including cholestyramine, theophylline and colestipol
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
King Edward Medical University, Mayo Hospital, Lahore
Lahore, Punjab Province, 54000
About this study
Official title: Effectiveness of Obeticholic Acid Versus Vitamin E in Patients of Non-alcoholic Fatty Liver Disease
This study was conducted on patients presenting to Mayo Hospital, Lahore from 24th August, 2023 till 23rd May, 2024. Ninety patients conforming to the inclusion criteria were selected via simple random sampling technique and divided into two groups. Group A received Obeticholic acid 10mg once a day and Group B received Vitamin E 400mg twice a day. Both treatments were given for 6 months alongwith clear written and informed instructions regarding lifestyle modification. Patients were followed at 3 and 6 months with ultrasound abdomen and serum alanine transferase levels.
Read the detailed description
This study was conducted in the Liver Clinic, patients presenting to the out-patients department and admitted on the Medical floor of Mayo Hospital, Lahore after taking approval from the Institutional Review Board of King Edward Medical University (KEMU) No. 166/RC/KEMU, dated 08-06-2023. A sample size of 90 patients (45 patients in each group) was estimated using 5% level of significance, 90% power of test with expected percentage improvement of fibrosis by ≥ 1 grade in obeticholic acid 10mg as 21% and vitamin E as 50%. Simple random sampling technique was employed in patient selection. Consenting adults of either gender between 18-75 years of age, diagnosed to have any grade of NAFLD on ultrasonography (Grade 1 to 3) and raised ALT >1.5 times the upper normal limit. (Normal reference <40 IU in males, <32 IU females) were included in the study. Patients with significant alcohol intake (more than 20 g/day in women and >30g/day in men), history of taking drugs that may cause fatty liver (i.e. tamoxifen, valproic acid, amiodarone, methotrexate, steroid, oral contraceptive pills), patients with co-morbid conditions like Diabetes, Chronic Obstructive Pulmonary Disease, Chronic Kidney Disease, Congestive Cardiac Failure, Hypothyroidism were excluded from the study. Pregnant and lactating females, patients with history of recent myocardial infarction, cirrhosis (decompensated liver) and portal hypertension, patients taking drugs known to have significant interaction with Obeticholic acid or vitamin E including cholestyramine, theophylline and colestipol were also excluded from the study protocol. After taking informed written and verbal consent, all patients conforming to the selection criteria were enrolled in the study. The patients were randomly enrolled into two groups of 45 patients each, by computer generated lottery method. Demographic details along with initial investigations were obtained i.e., liver function test (ALT) and Ultrasound Abdomen.
Group A patients were treated with Obeticholic acid 10mg once a day whereas Group B patients were treated with Vitamin E 400mg twice a day. Total duration of treatment was 6 months. Both groups of patients were advised dietary and lifestyle modification through a separate handout and counselling session. The patients were followed up at 3 and 6 months, at 3 months to ensure compliance to lifestyle and dietary modifications and medication, also ALT levels were checked.
At 6 months follow-up, patients were subjected to ultrasound evaluation as well as ALT level measurement. Data was recorded on a predesigned proforma. Effectiveness was defined in terms of improvement on ultrasonography by at least one grade or reduction of ALT by at least 25% from the baseline or both. All patients were guided to report if they experienced any adverse effects of medications. Non-compliance to medication due to any cause resulted in exclusion from the study.
Data was entered and analyzed using computer software SPSS 26.0 version. Quantitative variables like age, weight, ALT levels were presented as mean ± SD. Qualitative variables like gender, grade of NAFLD were presented as frequency and percentage. Independent sample t test was used to compare pre and post treatment ALT levels in both the groups. Chi square was applied for comparison of NAFLD grading pre and post treatment in both groups. p-value ≤0.05 was taken as significant.
- Conditions
- Non Alcoholic Fatty Liver Disease
- Being tested
- Obeticholic Acid 10 MG, Vitamin E 400mg
- Keywords
- Obeticholic acid, Vitamin E, Non-alcoholic Fatty Liver Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obeticholic Acid 10 MGDrug
Also called OCA
10mg OCA was given once daily for 6 months
Vitamin E 400mgDietary supplement
Also called Evion
Vitamin E 400mg was given twice daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Obeticholic acid (OCA) 10mg, Group A | Experimental | 45 patients received 10mg of Obeticholic acid daily for 6 months Receives: Drug: Obeticholic Acid 10 MG |
| Vitamin E 400mg twice daily, Group B | Active comparator | 45 patients received 400mg of Vitamin E twice daily for 6 months Receives: Dietary Supplement: Vitamin E 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in grade of NAFLD on ultrasound
Improvement/ reduction on ultrasonography of at least one grade of NAFLD from baseline
Measured: 6 months
Reduction of ALT levels
25% reduction of ALT levels from baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start24 Aug 2023
- Primary completion23 Nov 2023
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Non Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial. Patients were randomly divided into two groups. Group A received 10mg Obeticholic acid once daily, whereas Group B received 400mg Vitamin E twice daily. Both groups were treated for 6 months. Changes in grade of NAFLD on ultrasound and ALT levels were monitored.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tazeen Nazar, King Edward Medical University
- Investigators
- Tazeen Nazar, MBBS,FCPSMed, Study director, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104786
- Sponsor's protocol ID
- No.166/RC/KEMU Date 08/06/2023
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To maintain confidentiality.
Publications
Rinella ME, Lominadze Z, Loomba R, Charlton M, Neuschwander-Tetri BA, Caldwell SH, Kowdley K, Harrison SA. Practice patterns in NAFLD and NASH: real life differs from published guidelines. Ther Adv Gastroenterol. 2016 Jan;9(1):4-12. doi: 10.1177/1756283X15611581.
PubMed 26770262El Hadi H, Vettor R, Rossato M. Vitamin E as a Treatment for Nonalcoholic Fatty Liver Disease: Reality or Myth? Antioxidants (Basel). 2018 Jan 16;7(1):12. doi: 10.3390/antiox7010012.
PubMed 29337849Zhou J, Zhou F, Wang W, Zhang XJ, Ji YX, Zhang P, She ZG, Zhu L, Cai J, Li H. Epidemiological Features of NAFLD From 1999 to 2018 in China. Hepatology. 2020 May;71(5):1851-1864. doi: 10.1002/hep.31150.
PubMed 32012320Roy PP, Mahtab MA, Rahim MA, Yesmin SS, Islam SB, Akbar SMF. Treatment of Nonalcoholic Steatohepatitis by Obeticholic Acid: Current Status. Euroasian J Hepatogastroenterol. 2022 Jul;12(Suppl 1):S46-S50. doi: 10.5005/jp-journals-10018-1360.
PubMed 36466097Kamrul-Hasan A, Mondal S, Nagendra L, Sasikanth T, Ahammed A, Rahman S, Wickramarachchi A, Parajuli N, Khatiwada S, Dutta D. Role of Obeticholic Acid, a Farnesoid X Receptor Agonist, in Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-analysis. touchREV Endocrinol. 2024 Oct;20(2):54-61. doi: 10.17925/EE.2024.20.2.8. Epub 2024 Oct 9.
PubMed 3952604923. Abo Farrag GA, Afifi MA, El-Aziz SA, Ghoname MM, Ali AA. Role of Farnesoid X Receptor Ligand Obeticholic Acid Versus Vitamin E for Patients with Nonalcoholic Steatohepatitis. Al-Azhar International Medical Journal 2024; 5(10), Article 25. DOI: https://doi.org/10.58675/2682-339X.2706
Karedath J, Javed H, Ahsan Talpur F, Lal B, Kumari A, Kivan H, Anirudh Chunchu V, Hirani S. Effect of Vitamin E on Clinical Outcomes in Patients With Non-alcoholic Fatty Liver Disease: A Meta-Analysis. Cureus. 2022 Dec 21;14(12):e32764. doi: 10.7759/cureus.32764. eCollection 2022 Dec.
PubMed 36686141Zhao J, Li B, Zhang K, Zhu Z. The effect and safety of obeticholic acid for patients with nonalcoholic steatohepatitis: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2024 Feb 16;103(7):e37271. doi: 10.1097/MD.0000000000037271.
PubMed 3836390020. Aishwarya TS, Mounika N, Vishwakarma G, Adela R, Effect of obeticholic acid in non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) patients: a systematic review and meta-analysis, RPS Pharmacy and Pharmacology Reports, Volume 1, Issue 1, September 2022, rqac001, https://doi.org/10.1093/rpsppr/rqac001
Paternostro R, Trauner M. Current treatment of non-alcoholic fatty liver disease. J Intern Med. 2022 Aug;292(2):190-204. doi: 10.1111/joim.13531. Epub 2022 Jul 7.
PubMed 35796150Kulkarni AV, Tevethia HV, Arab JP, Candia R, Premkumar M, Kumar P, Sharma M, Reddy DN, Padaki NR. Efficacy and safety of obeticholic acid in liver disease-A systematic review and meta-analysis. Clin Res Hepatol Gastroenterol. 2021 May;45(3):101675. doi: 10.1016/j.clinre.2021.101675. Epub 2021 Mar 17.
PubMed 33722778Li J, Zou B, Yeo YH, Feng Y, Xie X, Lee DH, Fujii H, Wu Y, Kam LY, Ji F, Li X, Chien N, Wei M, Ogawa E, Zhao C, Wu X, Stave CD, Henry L, Barnett S, Takahashi H, Furusyo N, Eguchi Y, Hsu YC, Lee TY, Ren W, Qin C, Jun DW, Toyoda H, Wong VW, Cheung R, Zhu Q, Nguyen MH. Prevalence, incidence, and outcome of non-alcoholic fatty liver disease in Asia, 1999-2019: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2019 May;4(5):389-398. doi: 10.1016/S2468-1253(19)30039-1. Epub 2019 Mar 20.
PubMed 30902670Riazi K, Azhari H, Charette JH, Underwood FE, King JA, Afshar EE, Swain MG, Congly SE, Kaplan GG, Shaheen AA. The prevalence and incidence of NAFLD worldwide: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2022 Sep;7(9):851-861. doi: 10.1016/S2468-1253(22)00165-0. Epub 2022 Jul 5.
PubMed 35798021Le MH, Yeo YH, Li X, Li J, Zou B, Wu Y, Ye Q, Huang DQ, Zhao C, Zhang J, Liu C, Chang N, Xing F, Yan S, Wan ZH, Tang NSY, Mayumi M, Liu X, Liu C, Rui F, Yang H, Yang Y, Jin R, Le RHX, Xu Y, Le DM, Barnett S, Stave CD, Cheung R, Zhu Q, Nguyen MH. 2019 Global NAFLD Prevalence: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2809-2817.e28. doi: 10.1016/j.cgh.2021.12.002. Epub 2021 Dec 7.
PubMed 34890795Bril F, Biernacki DM, Kalavalapalli S, Lomonaco R, Subbarayan SK, Lai J, Tio F, Suman A, Orsak BK, Hecht J, Cusi K. Role of Vitamin E for Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2019 Aug;42(8):1481-1488. doi: 10.2337/dc19-0167. Epub 2019 May 21.
PubMed 31332029
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Obeticholic Acid Versus Vitamin E in Patients of Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT07104786
- Acronym / sponsor ID
- No.166/RC/KEMU Date 08/06/2023
- Conditions
- Non Alcoholic Fatty Liver Disease
- Keywords
- Obeticholic acid, Vitamin E, Non-alcoholic Fatty Liver Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted on patients presenting to Mayo Hospital, Lahore from 24th August, 2023 till 23rd May, 2024. Ninety patients conforming to the inclusion criteria were selected via simple random sampling technique and divided into two groups. Group A received Obeticholic acid 10mg once a day and Group B received Vitamin E 400mg twice a day. Both treatments were given for 6 months alongwith clear written and informed instructions regarding lifestyle modification. Patients were followed at 3 and 6 months with ultrasound abdomen and serum alanine transferase levels.
Detailed description
This study was conducted in the Liver Clinic, patients presenting to the out-patients department and admitted on the Medical floor of Mayo Hospital, Lahore after taking approval from the Institutional Review Board of King Edward Medical University (KEMU) No. 166/RC/KEMU, dated 08-06-2023. A sample size of 90 patients (45 patients in each group) was estimated using 5% level of significance, 90% power of test with expected percentage improvement of fibrosis by ≥ 1 grade in obeticholic acid 10mg as 21% and vitamin E as 50%. Simple random sampling technique was employed in patient selection. Consenting adults of either gender between 18-75 years of age, diagnosed to have any grade of NAFLD on ultrasonography (Grade 1 to 3) and raised ALT >1.5 times the upper normal limit. (Normal reference <40 IU in males, <32 IU females) were included in the study. Patients with significant alcohol intake (more than 20 g/day in women and >30g/day in men), history of taking drugs that may cause fatty liver (i.e. tamoxifen, valproic acid, amiodarone, methotrexate, steroid, oral contraceptive pills), patients with co-morbid conditions like Diabetes, Chronic Obstructive Pulmonary Disease, Chronic Kidney Disease, Congestive Cardiac Failure, Hypothyroidism were excluded from the study. Pregnant and lactating females, patients with history of recent myocardial infarction, cirrhosis (decompensated liver) and portal hypertension, patients taking drugs known to have significant interaction with Obeticholic acid or vitamin E including cholestyramine, theophylline and colestipol were also excluded from the study protocol. After taking informed written and verbal consent, all patients conforming to the selection criteria were enrolled in the study. The patients were randomly enrolled into two groups of 45 patients each, by computer generated lottery method. Demographic details along with initial investigations were obtained i.e., liver function test (ALT) and Ultrasound Abdomen.
Group A patients were treated with Obeticholic acid 10mg once a day whereas Group B patients were treated with Vitamin E 400mg twice a day. Total duration of treatment was 6 months. Both groups of patients were advised dietary and lifestyle modification through a separate handout and counselling session. The patients were followed up at 3 and 6 months, at 3 months to ensure compliance to lifestyle and dietary modifications and medication, also ALT levels were checked.
At 6 months follow-up, patients were subjected to ultrasound evaluation as well as ALT level measurement. Data was recorded on a predesigned proforma. Effectiveness was defined in terms of improvement on ultrasonography by at least one grade or reduction of ALT by at least 25% from the baseline or both. All patients were guided to report if they experienced any adverse effects of medications. Non-compliance to medication due to any cause resulted in exclusion from the study.
Data was entered and analyzed using computer software SPSS 26.0 version. Quantitative variables like age, weight, ALT levels were presented as mean ± SD. Qualitative variables like gender, grade of NAFLD were presented as frequency and percentage. Independent sample t test was used to compare pre and post treatment ALT levels in both the groups. Chi square was applied for comparison of NAFLD grading pre and post treatment in both groups. p-value ≤0.05 was taken as significant.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial. Patients were randomly divided into two groups. Group A received 10mg Obeticholic acid once daily, whereas Group B received 400mg Vitamin E twice daily. Both groups were treated for 6 months. Changes in grade of NAFLD on ultrasound and ALT levels were monitored.
| Arm | Type | Receives |
|---|---|---|
| Obeticholic acid (OCA) 10mg, Group A | Experimental | Drug: Obeticholic Acid 10 MG45 patients received 10mg of Obeticholic acid daily for 6 months |
| Vitamin E 400mg twice daily, Group B | Active comparator | Dietary Supplement: Vitamin E 400mg45 patients received 400mg of Vitamin E twice daily for 6 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consenting adults of either gender between 18-75 years of age
- Any grade of NAFLD on ultrasonography (Grade 1 to 3)
- Raised ALT >1.5 times the upper normal limit. (Normal reference <40 IU in males, <32 IU females)
Key exclusion criteria (6 listed)
- Patients with significant alcohol intake (more than 20 g/day in women and >30g/day in men)
- History of taking drugs that may cause fatty liver (i.e. tamoxifen, valproic acid, amiodarone, methotrexate, steroid, oral contraceptive pills)
- Patients with co-morbid conditions like Diabetes, Chronic Obstructive Pulmonary Disease, Chronic Kidney Disease, Congestive Cardiac Failure, Hypothyroidism
- Pregnant and lactating females
- Patients with history of recent myocardial infarction, cirrhosis (decompensated liver) and portal hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obeticholic Acid 10 MGAlso: OCA10mg OCA was given once daily for 6 months | Drug | Obeticholic acid (OCA) 10mg, Group A |
| Vitamin E 400mgAlso: EvionVitamin E 400mg was given twice daily for 6 months | Dietary supplement | Vitamin E 400mg twice daily, Group B |
Primary outcome
Change in grade of NAFLD on ultrasound
Time frame: 6 months
Improvement/ reduction on ultrasonography of at least one grade of NAFLD from baseline
Reduction of ALT levels
Time frame: 6 months
25% reduction of ALT levels from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Background: PubMed 26770262Rinella ME, Lominadze Z, Loomba R, Charlton M, Neuschwander-Tetri BA, Caldwell SH, Kowdley K, Harrison SA. Practice patterns in NAFLD and NASH: real life differs from published guidelines. Ther Adv Gastroenterol. 2016 Jan;9(1):4-12. doi: 10.1177/1756283X15611581.
- Background: PubMed 29337849El Hadi H, Vettor R, Rossato M. Vitamin E as a Treatment for Nonalcoholic Fatty Liver Disease: Reality or Myth? Antioxidants (Basel). 2018 Jan 16;7(1):12. doi: 10.3390/antiox7010012.
- Background: PubMed 32012320Zhou J, Zhou F, Wang W, Zhang XJ, Ji YX, Zhang P, She ZG, Zhu L, Cai J, Li H. Epidemiological Features of NAFLD From 1999 to 2018 in China. Hepatology. 2020 May;71(5):1851-1864. doi: 10.1002/hep.31150.
- Background: PubMed 36466097Roy PP, Mahtab MA, Rahim MA, Yesmin SS, Islam SB, Akbar SMF. Treatment of Nonalcoholic Steatohepatitis by Obeticholic Acid: Current Status. Euroasian J Hepatogastroenterol. 2022 Jul;12(Suppl 1):S46-S50. doi: 10.5005/jp-journals-10018-1360.
- Background: PubMed 39526049Kamrul-Hasan A, Mondal S, Nagendra L, Sasikanth T, Ahammed A, Rahman S, Wickramarachchi A, Parajuli N, Khatiwada S, Dutta D. Role of Obeticholic Acid, a Farnesoid X Receptor Agonist, in Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-analysis. touchREV Endocrinol. 2024 Oct;20(2):54-61. doi: 10.17925/EE.2024.20.2.8. Epub 2024 Oct 9.
- Background23. Abo Farrag GA, Afifi MA, El-Aziz SA, Ghoname MM, Ali AA. Role of Farnesoid X Receptor Ligand Obeticholic Acid Versus Vitamin E for Patients with Nonalcoholic Steatohepatitis. Al-Azhar International Medical Journal 2024; 5(10), Article 25. DOI: https://doi.org/10.58675/2682-339X.2706
- Background: PubMed 36686141Karedath J, Javed H, Ahsan Talpur F, Lal B, Kumari A, Kivan H, Anirudh Chunchu V, Hirani S. Effect of Vitamin E on Clinical Outcomes in Patients With Non-alcoholic Fatty Liver Disease: A Meta-Analysis. Cureus. 2022 Dec 21;14(12):e32764. doi: 10.7759/cureus.32764. eCollection 2022 Dec.
- Background: PubMed 38363900Zhao J, Li B, Zhang K, Zhu Z. The effect and safety of obeticholic acid for patients with nonalcoholic steatohepatitis: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2024 Feb 16;103(7):e37271. doi: 10.1097/MD.0000000000037271.
- Background20. Aishwarya TS, Mounika N, Vishwakarma G, Adela R, Effect of obeticholic acid in non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) patients: a systematic review and meta-analysis, RPS Pharmacy and Pharmacology Reports, Volume 1, Issue 1, September 2022, rqac001, https://doi.org/10.1093/rpsppr/rqac001
- Background: PubMed 35796150Paternostro R, Trauner M. Current treatment of non-alcoholic fatty liver disease. J Intern Med. 2022 Aug;292(2):190-204. doi: 10.1111/joim.13531. Epub 2022 Jul 7.
- Background: PubMed 33722778Kulkarni AV, Tevethia HV, Arab JP, Candia R, Premkumar M, Kumar P, Sharma M, Reddy DN, Padaki NR. Efficacy and safety of obeticholic acid in liver disease-A systematic review and meta-analysis. Clin Res Hepatol Gastroenterol. 2021 May;45(3):101675. doi: 10.1016/j.clinre.2021.101675. Epub 2021 Mar 17.
- Background: PubMed 30902670Li J, Zou B, Yeo YH, Feng Y, Xie X, Lee DH, Fujii H, Wu Y, Kam LY, Ji F, Li X, Chien N, Wei M, Ogawa E, Zhao C, Wu X, Stave CD, Henry L, Barnett S, Takahashi H, Furusyo N, Eguchi Y, Hsu YC, Lee TY, Ren W, Qin C, Jun DW, Toyoda H, Wong VW, Cheung R, Zhu Q, Nguyen MH. Prevalence, incidence, and outcome of non-alcoholic fatty liver disease in Asia, 1999-2019: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2019 May;4(5):389-398. doi: 10.1016/S2468-1253(19)30039-1. Epub 2019 Mar 20.
- Individual participant dataSharing planned: No. To maintain confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tazeen Nazar, MBBS,FCPSMed study director
King Edward Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obeticholic Acid 10 MG and Vitamin E 400mg in people with Non Alcoholic Fatty Liver Disease, run by King Edward Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in grade of NAFLD on ultrasound (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07104786, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.